Many individuals in hospitals or nursing homes cannot orally take nourishment or medication. These individuals, or medical patients, typically receive medical fluids containing the requisite nourishment and/or medication intravenously or enterally via a patient feeding line that is connected to a container holding such medical fluids. These medical fluids are commonly packaged in flexible containers, for example flexible pouches. Such a pouch is typically constructed from two webs of plastic film that have a series of edge seals so as to form a bag defining a reservoir to contain the medical fluid. A closure device is placed between the webs during the sealing process to create a communication between the reservoir and the patient feeding line.
The medical fluids that are typically administered to a patient need to be sterile. Thus, the seal created by the closure device between the flexible pouch and the patient feeding line should be airtight. The closure device serves to prevent contaminants from entering the patient feeding line and harming the patient. Moreover, for oxygen sensitive medical fluids, the closure device prevents oxygen from entering the opening of the flexible pouch.
Prior art closure devices typically have a single barrier that prevents the contents of the container from being exposed to the environment. In the event that this barrier ruptures, for example during a retorting process, the medical fluid would leak from the container and be exposed to non-sterile conditions and oxygen. Prior methods of maintaining sterility have also included swabbing or wiping the outside surface of the closure device with alcohol prior to spiking.
Furthermore, the barrier of closure devices are typically located near the opening of the package itself, medical fluid commonly leaks from the container as a conventional spike set, or spike, is used to puncture the barrier. An example of a conventional spike set is COMPAT® piercing spike sets distributed by Novartis Nutrition Corporation (Minneapolis, Minn.).
Thus, there is a need for a novel closure device that presents additional protection in the event that the closure device ever ruptures by featuring multiple protection mechanisms. Furthermore, the novel closure device must be easily implemented in a flexible pouch system and be compatible with flexible spikes.